Cashing In On Medical Knowledge

Cashing In On Medical Knowledge

The intent of the patent system is, as Abraham Lincoln once put it, to add the fuel of interest to the fire of genius by granting inventors financial rewards. In the knowledge-based economy, however, the researchers who obtain the patent on a biological process are frequently not the ones who do the work to bring a product to market. Even Forbes magazine, the self-described capitalist tool, complained about this aspect of the patent system. Forbes’ editors wrote in 1994 that the U.S. patent process has too often “become a lottery in which one lucky inventor gets sweeping rights to a whole class of inventions, and stymies development by others.”

Forbes was not speaking specifically about the biomedical field, but the observation seems prescient as the Bogart/Kaiser case heads to court in California. But is this kind of a lottery just? Should anyone be allowed to patent a function of the human body, or a medical method or procedure? As in most patent infringement cases, the court will likely not tackle those broader questions. Instead the case will probably focus on narrow legal questions. Much of Kaiser’s case, for example, will center on the argument that the modern-day multiple-marker prenatal test is only distantly related to the original research Bogart patented.

Bogart noted a correlation between Down’s syndrome and high levels of the hormone HCG. But, in as many as 30 percent of cases, the elevated HCG levels do not correspond to the presence of the birth defect. To make a more reliable test, researchers developed a technique that drew upon other insights similar to Bogart’s to screen the blood for the levels of two chemicals aside from HCG. The combined indicators considerably enhance the efficacy of the test not only for Down’s syndrome but for other birth defects as well.Mike Jacobs, an attorney at Morrison & Foerster representing Kaiser Permanente in the case, notes that articles in the medical literature, including a letter in the prestigious British medical journal Lancet, on the correlation between HCG and fetal abnormalities actually predate Bogart’s observation. Jacobs hopes that fact may ultimately invalidate Bogart’s claim. Even if Bogart does deserve credit for discovering-or at least sharpening-our realization of the correlation between HCG and the probability of Down’s syndrome, says Kaiser’s Sugarman, “his financially motivated claim does nothing to benefit medical science.”

With the courts focusing on narrow issues, and the executive branch declining to intervene, only Congress is left to stem the inroads of private ownership into the shared pool of advancing medical knowledge. The Bogart case may inspire that. It has undergone close scrutiny by Greg Ganske, the Iowa Republican largely responsible for the 1996 congressional bill’s passage. “Maybe with examples like this,” Ganske says, “we will need to go back at this issue again.”

For his part, Jack Singer, who persevered-and prevailed- in the cataract-surgery case, says he is “deeply troubled” by the Bogart case. Only patent owners and their lawyers benefit from carving up medical knowledge into privately held parcels, Singer argues. “Patients, the medical profession, and society all benefit from the long-standing culture of free exchange of medical knowledge.”

But as the knowledge-based economy evolves, such arguments must be balanced against the claims of technological progress. If anything is clear in this increasingly tangled field, it is that there will not be simple answers anytime soon.